Surgical Oncology

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

Lymph node counts of 12 or higher, widely considered a key marker of surgical quality in colon cancer resection, had no significant effect on 5-year survival rates in settings where surgeons are audited and credentialed and where surgical techniques are standardized.

Lymph node (LN) count is one of several measures used to determine the extent of surgical resection and an indicator of clear surgical margins, which have been assumed to result in better survival outcomes for colon cancer patients. A new data analysis, however, of the COST (Clinical Outcomes of Surgical Therapy) trial suggests reevaluating the use of surgical surrogates such as 12 LNs and margins.

The COST trial, a large, multicenter randomized trial of colon cancer procedures, compared outcomes for laparoscopic and open techniques in treating colon adenocarcinoma. The trial collected data on a number of surgical variables, including tumor location and LN count. A total of 787 patients were included: 267 with stage I disease, 284 with stage II, and 236 with stage III. Their median age was 70 years, and 50% were male.

In the current study, Dr. Kellie L. Mathis of the Mayo Clinic in Rochester, Minn., and her colleagues found that 5-year overall and disease-free survival were not influenced by LN count of above or below 12 (Ann. Surg. 2012;257:102-7 [doi:10.1097/SLA.0b013e318260a8e6]). When they adjusted for age and cancer stage, LN count was seen as not predictive of overall or disease-free survival (P = .60).

Other surgical surrogates, including total bowel length, margins, or mesenteric length, likewise did not have a significant effect on survival (P greater than .05 for all), nor did tumor location (right, left, or sigmoid), surgical technique (laparoscopic or open), and sex. Only patient age and cancer stage were found to be predictive of survival.

"On the basis of abundant literature and the acceptance of the 12 LN count as a surgical quality surrogate by National Quality Forum, most would expect the 12 LN count or other surgical variables to be predictive of survival," Dr. Mathis and her associates wrote. However, they hypothesized that procedural standardization, monitoring, and credentialing may provide a better strategy for quality control.

Overall 5-year survival results from the COST trial, they noted, were 77.2% – better than national rates for comparable patient groups in the same time period. All enrolling surgeons underwent pretrial credentialing and had performed a minimum of 20 laparoscopic colon resections, for which they had submitted operative and pathology reports. All laparoscopic resections were video recorded, and videos were randomly audited by an external review committee.

If the observations in the current study can be validated by others, Dr. Mathis and her colleagues said, "we submit that now is the time to invest in the development of technical quality control programs that directly measure and monitor surgical procedures."

Dr. Mathis and her colleagues stated that they had no conflicts of interest related to their findings.

Lymph node counts of 12 or higher, widely considered a key marker of surgical quality in colon cancer resection, had no significant effect on 5-year survival rates in settings where surgeons are audited and credentialed and where surgical techniques are standardized.

Lymph node (LN) count is one of several measures used to determine the extent of surgical resection and an indicator of clear surgical margins, which have been assumed to result in better survival outcomes for colon cancer patients. A new data analysis, however, of the COST (Clinical Outcomes of Surgical Therapy) trial suggests reevaluating the use of surgical surrogates such as 12 LNs and margins.

The COST trial, a large, multicenter randomized trial of colon cancer procedures, compared outcomes for laparoscopic and open techniques in treating colon adenocarcinoma. The trial collected data on a number of surgical variables, including tumor location and LN count. A total of 787 patients were included: 267 with stage I disease, 284 with stage II, and 236 with stage III. Their median age was 70 years, and 50% were male.

In the current study, Dr. Kellie L. Mathis of the Mayo Clinic in Rochester, Minn., and her colleagues found that 5-year overall and disease-free survival were not influenced by LN count of above or below 12 (Ann. Surg. 2012;257:102-7 [doi:10.1097/SLA.0b013e318260a8e6]). When they adjusted for age and cancer stage, LN count was seen as not predictive of overall or disease-free survival (P = .60).

Other surgical surrogates, including total bowel length, margins, or mesenteric length, likewise did not have a significant effect on survival (P greater than .05 for all), nor did tumor location (right, left, or sigmoid), surgical technique (laparoscopic or open), and sex. Only patient age and cancer stage were found to be predictive of survival.

"On the basis of abundant literature and the acceptance of the 12 LN count as a surgical quality surrogate by National Quality Forum, most would expect the 12 LN count or other surgical variables to be predictive of survival," Dr. Mathis and her associates wrote. However, they hypothesized that procedural standardization, monitoring, and credentialing may provide a better strategy for quality control.

Overall 5-year survival results from the COST trial, they noted, were 77.2% – better than national rates for comparable patient groups in the same time period. All enrolling surgeons underwent pretrial credentialing and had performed a minimum of 20 laparoscopic colon resections, for which they had submitted operative and pathology reports. All laparoscopic resections were video recorded, and videos were randomly audited by an external review committee.

If the observations in the current study can be validated by others, Dr. Mathis and her colleagues said, "we submit that now is the time to invest in the development of technical quality control programs that directly measure and monitor surgical procedures."

Dr. Mathis and her colleagues stated that they had no conflicts of interest related to their findings.

Lymph node counts of 12 or higher, widely considered a key marker of surgical quality in colon cancer resection, had no significant effect on 5-year survival rates in settings where surgeons are audited and credentialed and where surgical techniques are standardized.

Lymph node (LN) count is one of several measures used to determine the extent of surgical resection and an indicator of clear surgical margins, which have been assumed to result in better survival outcomes for colon cancer patients. A new data analysis, however, of the COST (Clinical Outcomes of Surgical Therapy) trial suggests reevaluating the use of surgical surrogates such as 12 LNs and margins.

The COST trial, a large, multicenter randomized trial of colon cancer procedures, compared outcomes for laparoscopic and open techniques in treating colon adenocarcinoma. The trial collected data on a number of surgical variables, including tumor location and LN count. A total of 787 patients were included: 267 with stage I disease, 284 with stage II, and 236 with stage III. Their median age was 70 years, and 50% were male.

In the current study, Dr. Kellie L. Mathis of the Mayo Clinic in Rochester, Minn., and her colleagues found that 5-year overall and disease-free survival were not influenced by LN count of above or below 12 (Ann. Surg. 2012;257:102-7 [doi:10.1097/SLA.0b013e318260a8e6]). When they adjusted for age and cancer stage, LN count was seen as not predictive of overall or disease-free survival (P = .60).

Other surgical surrogates, including total bowel length, margins, or mesenteric length, likewise did not have a significant effect on survival (P greater than .05 for all), nor did tumor location (right, left, or sigmoid), surgical technique (laparoscopic or open), and sex. Only patient age and cancer stage were found to be predictive of survival.

"On the basis of abundant literature and the acceptance of the 12 LN count as a surgical quality surrogate by National Quality Forum, most would expect the 12 LN count or other surgical variables to be predictive of survival," Dr. Mathis and her associates wrote. However, they hypothesized that procedural standardization, monitoring, and credentialing may provide a better strategy for quality control.

Overall 5-year survival results from the COST trial, they noted, were 77.2% – better than national rates for comparable patient groups in the same time period. All enrolling surgeons underwent pretrial credentialing and had performed a minimum of 20 laparoscopic colon resections, for which they had submitted operative and pathology reports. All laparoscopic resections were video recorded, and videos were randomly audited by an external review committee.

If the observations in the current study can be validated by others, Dr. Mathis and her colleagues said, "we submit that now is the time to invest in the development of technical quality control programs that directly measure and monitor surgical procedures."

Dr. Mathis and her colleagues stated that they had no conflicts of interest related to their findings.

PALM BEACH, FLA. – Simultaneous and staged removal of primary colorectal cancer and associated liver metastases worked equally well, a review of more than 1,000 cases at four international centers has shown.

"Long-term outcome of patients with synchronous colorectal liver metastases is dictated by biology, not by surgical strategy," Dr. Timothy M. Pawlik, FACS, said at the annual meeting of the Southern Surgical Association.

About a quarter of patients with advanced colorectal cancer present with synchronous liver metastases, and surgeons have used three different resection strategies. The classic approach has been staged removal of the primary, colorectal cancer first, followed by removal of the liver disease in a separate operation at a later time. In a much smaller number of cases, the staged approach is reversed, with initial excision of the liver disease followed later by removal of the primary tumor. The third option has been to do both excisions during a single operation. Until now, assessments that compared these approaches mostly have used data from a single center, and in several cases the reviews included relatively few patients, said Dr. Pawlik, a surgical oncologist at Johns Hopkins University in Baltimore.

The review done by Dr. Pawlik and his associates involved 1,004 patients treated between 1982 and 2011 at four major hepatobiliary centers in the United States and Europe. The series included 647 patients treated by removal of their primary colorectal tumor followed by a second surgery to remove their liver metastases, 329 patients who had both excisions done during a single operation, and 28 patients who had their liver metastases removed first and then had the primary tumor removed in a second operation.

The data showed no statistically significant difference for any outcome measure, including the incidence of complications, 90-day mortality, local recurrences, median survival, or rate of 5-year survival. For example, during a median follow-up of 34 months, the recurrence rate was 57% among patients treated with a classic, staged approach and 60% among patients who had a simultaneous excision, a difference that was not statistically significant. And in a multivariate regression analysis of factors associated with mortality during follow-up, simultaneous excision linked with an 8% higher mortality rate relative to a classic staged approach, but again the difference was not statistically significant.

"Long-term survival was associated with the location and extent of disease, but not with the surgical strategy," Dr. Pawlik said.

But he also qualified these findings with a couple of caveats. First, the findings "should only be extrapolated to academic centers, major hepatobiliary centers. The findings cannot be extrapolated to the community setting," he said.

Second, he agreed with the discussants of his report that a prospective, randomized trial should be done to definitively prove that surgical strategy has no impact on outcomes.

Dr. Pawlik said he had no relevant financial disclosures.

[email protected]

On Twitter @mitchelzoler

PALM BEACH, FLA. – Simultaneous and staged removal of primary colorectal cancer and associated liver metastases worked equally well, a review of more than 1,000 cases at four international centers has shown.

"Long-term outcome of patients with synchronous colorectal liver metastases is dictated by biology, not by surgical strategy," Dr. Timothy M. Pawlik, FACS, said at the annual meeting of the Southern Surgical Association.

About a quarter of patients with advanced colorectal cancer present with synchronous liver metastases, and surgeons have used three different resection strategies. The classic approach has been staged removal of the primary, colorectal cancer first, followed by removal of the liver disease in a separate operation at a later time. In a much smaller number of cases, the staged approach is reversed, with initial excision of the liver disease followed later by removal of the primary tumor. The third option has been to do both excisions during a single operation. Until now, assessments that compared these approaches mostly have used data from a single center, and in several cases the reviews included relatively few patients, said Dr. Pawlik, a surgical oncologist at Johns Hopkins University in Baltimore.

The review done by Dr. Pawlik and his associates involved 1,004 patients treated between 1982 and 2011 at four major hepatobiliary centers in the United States and Europe. The series included 647 patients treated by removal of their primary colorectal tumor followed by a second surgery to remove their liver metastases, 329 patients who had both excisions done during a single operation, and 28 patients who had their liver metastases removed first and then had the primary tumor removed in a second operation.

The data showed no statistically significant difference for any outcome measure, including the incidence of complications, 90-day mortality, local recurrences, median survival, or rate of 5-year survival. For example, during a median follow-up of 34 months, the recurrence rate was 57% among patients treated with a classic, staged approach and 60% among patients who had a simultaneous excision, a difference that was not statistically significant. And in a multivariate regression analysis of factors associated with mortality during follow-up, simultaneous excision linked with an 8% higher mortality rate relative to a classic staged approach, but again the difference was not statistically significant.

"Long-term survival was associated with the location and extent of disease, but not with the surgical strategy," Dr. Pawlik said.

But he also qualified these findings with a couple of caveats. First, the findings "should only be extrapolated to academic centers, major hepatobiliary centers. The findings cannot be extrapolated to the community setting," he said.

Second, he agreed with the discussants of his report that a prospective, randomized trial should be done to definitively prove that surgical strategy has no impact on outcomes.

Dr. Pawlik said he had no relevant financial disclosures.

[email protected]

On Twitter @mitchelzoler

PALM BEACH, FLA. – Simultaneous and staged removal of primary colorectal cancer and associated liver metastases worked equally well, a review of more than 1,000 cases at four international centers has shown.

"Long-term outcome of patients with synchronous colorectal liver metastases is dictated by biology, not by surgical strategy," Dr. Timothy M. Pawlik, FACS, said at the annual meeting of the Southern Surgical Association.

About a quarter of patients with advanced colorectal cancer present with synchronous liver metastases, and surgeons have used three different resection strategies. The classic approach has been staged removal of the primary, colorectal cancer first, followed by removal of the liver disease in a separate operation at a later time. In a much smaller number of cases, the staged approach is reversed, with initial excision of the liver disease followed later by removal of the primary tumor. The third option has been to do both excisions during a single operation. Until now, assessments that compared these approaches mostly have used data from a single center, and in several cases the reviews included relatively few patients, said Dr. Pawlik, a surgical oncologist at Johns Hopkins University in Baltimore.

The review done by Dr. Pawlik and his associates involved 1,004 patients treated between 1982 and 2011 at four major hepatobiliary centers in the United States and Europe. The series included 647 patients treated by removal of their primary colorectal tumor followed by a second surgery to remove their liver metastases, 329 patients who had both excisions done during a single operation, and 28 patients who had their liver metastases removed first and then had the primary tumor removed in a second operation.

The data showed no statistically significant difference for any outcome measure, including the incidence of complications, 90-day mortality, local recurrences, median survival, or rate of 5-year survival. For example, during a median follow-up of 34 months, the recurrence rate was 57% among patients treated with a classic, staged approach and 60% among patients who had a simultaneous excision, a difference that was not statistically significant. And in a multivariate regression analysis of factors associated with mortality during follow-up, simultaneous excision linked with an 8% higher mortality rate relative to a classic staged approach, but again the difference was not statistically significant.

"Long-term survival was associated with the location and extent of disease, but not with the surgical strategy," Dr. Pawlik said.

But he also qualified these findings with a couple of caveats. First, the findings "should only be extrapolated to academic centers, major hepatobiliary centers. The findings cannot be extrapolated to the community setting," he said.

Second, he agreed with the discussants of his report that a prospective, randomized trial should be done to definitively prove that surgical strategy has no impact on outcomes.

Dr. Pawlik said he had no relevant financial disclosures.

[email protected]

On Twitter @mitchelzoler

SAN ANTONIO – Women undergoing neoadjuvant chemotherapy for node-positive breast cancer may be able to have sentinel lymph node surgery instead of an axillary lymph node dissection, but proper surgical technique is critical for staging accuracy, a phase II trial from the American College of Surgeons Oncology Group suggests.

Among the 637 women studied in ACOSOG Z1071, all received chemotherapy and then underwent both sentinel lymph node (SLN) surgery and axillary lymph node dissection (ALND). SLN surgery correctly identified nodal status in 91.2% of cases, lead investigator Dr. Judy C. Boughey reported at the San Antonio Breast Cancer Symposium.

The false-negative rate of SLN averaged 12.6% in women with clinical N1 disease who had at least two sentinel nodes examined – slightly higher than the 10% set as a predefined endpoint. But it was lower when both blue dye and radiolabeled colloid were used to identify sentinel nodes (10.8%) and when three or more sentinel nodes were examined (9.1%).

"SLN surgery is a useful tool for detecting residual nodal disease in those women who present with node-positive breast cancer receiving neoadjuvant chemotherapy," Dr. Boughey commented in a press briefing. "Using SLN surgery in this patient population will enable us to reduce the extent of axillary surgery and therefore decrease morbidities for women treated for breast cancer."

Women were eligible for the trial if they had node-positive (T0-4, N1-2) breast cancer. After neoadjuvant chemotherapy, they underwent definitive breast surgery (lumpectomy or mastectomy), along with SLN surgery followed by a completion ALND. Patients who had N3 disease, inflammatory breast cancer, or prior ipsilateral axillary surgery were excluded.

Nodes were defined as being positive if they contained a tumor deposit measuring greater than 0.2 mm on sections stained with hematoxylin and eosin.

Sentinel nodes were identified in 92.7% of patients overall. A total of 40% of patients had no detectable nodal disease after neoadjuvant chemotherapy and thus would be unlikely to benefit from undergoing ALND, according to Dr. Boughey, a surgeon at the Mayo Clinic in Rochester, Minn.

Among the 60% of patients with detectable nodal disease (subsequently used to assess the false-negative rate of SLN), 85% had only positive sentinel nodes.

When only a single SLN was examined, the false-negative rate of SLN surgery was 31.5%, so Dr. Boughey recommends resecting a minimum of two nodes.

The false-negative rate was also lower when sentinel nodes were pathologically examined and determined to contain histologic changes (10.8%) and when a clip placed in the node at initial diagnosis was subsequently found at definitive surgery (7.4%).

"It’s important to collaborate with our radiology colleagues regarding potential for clip placement in lymph nodes, as well as our pathologists for review of sentinel lymph nodes for the presence of treatment effect," she said.

In the session where the results were presented, Dr. J. Michael Dixon of the Western General Hospital in Edinburgh asked whether a minimum of three nodes should be taken, because "if you take three or more nodes, your false-negative rate is within the range that is acceptable. Yet your conclusions said two. So I wonder if you get a second chance, you can tell us that we can do this technique if we use dual isotope and if we take three or more sentinel nodes and follow your other rules."

"We framed the conclusion based on the way the protocol had been written up front with two or more, but I think your comments are spot on," replied Dr. Boughey.

Dr. Steven Vogl of the Montefiore Medical Center in the Bronx, New York, asked about pathologic complete response (pCR).

"We did not require any specific degree of response for the patients to be in the study, since all of the patients were getting a completion ALND," Dr. Boughey replied. "We are currently evaluating specifically that question about whether the breast response and/or the nodal response on ultrasound can help define the appropriate patient population for us to tailor this therapy to."

Dr. Vogl noted that for patients who are HER2-positive, ER-negative, and triple-negative, pCR is very important. "So if we can figure out very carefully who didn’t achieve a pCR, especially in the node, we can probably do something for those patients some day with the right agents," he said.

"Do you use clips in all patients? Do you use dual agents always? And do you always remove two sentinel nodes? What is the impact of this on what we should do next?" asked session moderator Dr. Anthony Lucci Jr., of the University of Texas M.D. Anderson Cancer Center in Houston.

Dr. Boughey replied, "The take-home message is ... I’ll be looking at clip placement, making sure that we use dual-agent tracer for these cases, and ensuring that we do a thorough evaluation of the axilla and resecting any node that is radioactive, blue, or palpable.

"One of the concerns always when you are doing the sentinel node and you know you are doing a planned dissection [thereafter] is that the completeness of the evaluation of the axilla may not be quite as thorough as if you are closing as soon as you finish that sentinel node biopsy. So I think that is where the onus rests on the surgeon, so that we thoroughly evaluate the axilla and ensure this technique is as thorough as possible," she added.

In an additional analysis of patients with clinical N2 disease, the false-negative rate of SLN was 0%.

"Further work is under way regarding the secondary endpoint of this study, which will look at correlating the axillary ultrasound after chemotherapy with the false-negative rate. ... Maybe this can help improve patient selection for the procedure and further lower the false-negative rate," Dr. Boughey said. "We are also continuing to work to evaluate lymphedema rates and quality of life in these patients."

Dr. Boughey disclosed no relevant conflicts of interest.

SAN ANTONIO – Women undergoing neoadjuvant chemotherapy for node-positive breast cancer may be able to have sentinel lymph node surgery instead of an axillary lymph node dissection, but proper surgical technique is critical for staging accuracy, a phase II trial from the American College of Surgeons Oncology Group suggests.

Among the 637 women studied in ACOSOG Z1071, all received chemotherapy and then underwent both sentinel lymph node (SLN) surgery and axillary lymph node dissection (ALND). SLN surgery correctly identified nodal status in 91.2% of cases, lead investigator Dr. Judy C. Boughey reported at the San Antonio Breast Cancer Symposium.

The false-negative rate of SLN averaged 12.6% in women with clinical N1 disease who had at least two sentinel nodes examined – slightly higher than the 10% set as a predefined endpoint. But it was lower when both blue dye and radiolabeled colloid were used to identify sentinel nodes (10.8%) and when three or more sentinel nodes were examined (9.1%).

"SLN surgery is a useful tool for detecting residual nodal disease in those women who present with node-positive breast cancer receiving neoadjuvant chemotherapy," Dr. Boughey commented in a press briefing. "Using SLN surgery in this patient population will enable us to reduce the extent of axillary surgery and therefore decrease morbidities for women treated for breast cancer."

Women were eligible for the trial if they had node-positive (T0-4, N1-2) breast cancer. After neoadjuvant chemotherapy, they underwent definitive breast surgery (lumpectomy or mastectomy), along with SLN surgery followed by a completion ALND. Patients who had N3 disease, inflammatory breast cancer, or prior ipsilateral axillary surgery were excluded.

Nodes were defined as being positive if they contained a tumor deposit measuring greater than 0.2 mm on sections stained with hematoxylin and eosin.

Sentinel nodes were identified in 92.7% of patients overall. A total of 40% of patients had no detectable nodal disease after neoadjuvant chemotherapy and thus would be unlikely to benefit from undergoing ALND, according to Dr. Boughey, a surgeon at the Mayo Clinic in Rochester, Minn.

Among the 60% of patients with detectable nodal disease (subsequently used to assess the false-negative rate of SLN), 85% had only positive sentinel nodes.

When only a single SLN was examined, the false-negative rate of SLN surgery was 31.5%, so Dr. Boughey recommends resecting a minimum of two nodes.

The false-negative rate was also lower when sentinel nodes were pathologically examined and determined to contain histologic changes (10.8%) and when a clip placed in the node at initial diagnosis was subsequently found at definitive surgery (7.4%).

"It’s important to collaborate with our radiology colleagues regarding potential for clip placement in lymph nodes, as well as our pathologists for review of sentinel lymph nodes for the presence of treatment effect," she said.

In the session where the results were presented, Dr. J. Michael Dixon of the Western General Hospital in Edinburgh asked whether a minimum of three nodes should be taken, because "if you take three or more nodes, your false-negative rate is within the range that is acceptable. Yet your conclusions said two. So I wonder if you get a second chance, you can tell us that we can do this technique if we use dual isotope and if we take three or more sentinel nodes and follow your other rules."

"We framed the conclusion based on the way the protocol had been written up front with two or more, but I think your comments are spot on," replied Dr. Boughey.

Dr. Steven Vogl of the Montefiore Medical Center in the Bronx, New York, asked about pathologic complete response (pCR).

"We did not require any specific degree of response for the patients to be in the study, since all of the patients were getting a completion ALND," Dr. Boughey replied. "We are currently evaluating specifically that question about whether the breast response and/or the nodal response on ultrasound can help define the appropriate patient population for us to tailor this therapy to."

Dr. Vogl noted that for patients who are HER2-positive, ER-negative, and triple-negative, pCR is very important. "So if we can figure out very carefully who didn’t achieve a pCR, especially in the node, we can probably do something for those patients some day with the right agents," he said.

"Do you use clips in all patients? Do you use dual agents always? And do you always remove two sentinel nodes? What is the impact of this on what we should do next?" asked session moderator Dr. Anthony Lucci Jr., of the University of Texas M.D. Anderson Cancer Center in Houston.

Dr. Boughey replied, "The take-home message is ... I’ll be looking at clip placement, making sure that we use dual-agent tracer for these cases, and ensuring that we do a thorough evaluation of the axilla and resecting any node that is radioactive, blue, or palpable.

"One of the concerns always when you are doing the sentinel node and you know you are doing a planned dissection [thereafter] is that the completeness of the evaluation of the axilla may not be quite as thorough as if you are closing as soon as you finish that sentinel node biopsy. So I think that is where the onus rests on the surgeon, so that we thoroughly evaluate the axilla and ensure this technique is as thorough as possible," she added.

In an additional analysis of patients with clinical N2 disease, the false-negative rate of SLN was 0%.

"Further work is under way regarding the secondary endpoint of this study, which will look at correlating the axillary ultrasound after chemotherapy with the false-negative rate. ... Maybe this can help improve patient selection for the procedure and further lower the false-negative rate," Dr. Boughey said. "We are also continuing to work to evaluate lymphedema rates and quality of life in these patients."

Dr. Boughey disclosed no relevant conflicts of interest.

SAN ANTONIO – Women undergoing neoadjuvant chemotherapy for node-positive breast cancer may be able to have sentinel lymph node surgery instead of an axillary lymph node dissection, but proper surgical technique is critical for staging accuracy, a phase II trial from the American College of Surgeons Oncology Group suggests.

Among the 637 women studied in ACOSOG Z1071, all received chemotherapy and then underwent both sentinel lymph node (SLN) surgery and axillary lymph node dissection (ALND). SLN surgery correctly identified nodal status in 91.2% of cases, lead investigator Dr. Judy C. Boughey reported at the San Antonio Breast Cancer Symposium.

The false-negative rate of SLN averaged 12.6% in women with clinical N1 disease who had at least two sentinel nodes examined – slightly higher than the 10% set as a predefined endpoint. But it was lower when both blue dye and radiolabeled colloid were used to identify sentinel nodes (10.8%) and when three or more sentinel nodes were examined (9.1%).

"SLN surgery is a useful tool for detecting residual nodal disease in those women who present with node-positive breast cancer receiving neoadjuvant chemotherapy," Dr. Boughey commented in a press briefing. "Using SLN surgery in this patient population will enable us to reduce the extent of axillary surgery and therefore decrease morbidities for women treated for breast cancer."

Women were eligible for the trial if they had node-positive (T0-4, N1-2) breast cancer. After neoadjuvant chemotherapy, they underwent definitive breast surgery (lumpectomy or mastectomy), along with SLN surgery followed by a completion ALND. Patients who had N3 disease, inflammatory breast cancer, or prior ipsilateral axillary surgery were excluded.

Nodes were defined as being positive if they contained a tumor deposit measuring greater than 0.2 mm on sections stained with hematoxylin and eosin.

Sentinel nodes were identified in 92.7% of patients overall. A total of 40% of patients had no detectable nodal disease after neoadjuvant chemotherapy and thus would be unlikely to benefit from undergoing ALND, according to Dr. Boughey, a surgeon at the Mayo Clinic in Rochester, Minn.

Among the 60% of patients with detectable nodal disease (subsequently used to assess the false-negative rate of SLN), 85% had only positive sentinel nodes.

When only a single SLN was examined, the false-negative rate of SLN surgery was 31.5%, so Dr. Boughey recommends resecting a minimum of two nodes.

The false-negative rate was also lower when sentinel nodes were pathologically examined and determined to contain histologic changes (10.8%) and when a clip placed in the node at initial diagnosis was subsequently found at definitive surgery (7.4%).

"It’s important to collaborate with our radiology colleagues regarding potential for clip placement in lymph nodes, as well as our pathologists for review of sentinel lymph nodes for the presence of treatment effect," she said.

In the session where the results were presented, Dr. J. Michael Dixon of the Western General Hospital in Edinburgh asked whether a minimum of three nodes should be taken, because "if you take three or more nodes, your false-negative rate is within the range that is acceptable. Yet your conclusions said two. So I wonder if you get a second chance, you can tell us that we can do this technique if we use dual isotope and if we take three or more sentinel nodes and follow your other rules."

"We framed the conclusion based on the way the protocol had been written up front with two or more, but I think your comments are spot on," replied Dr. Boughey.

Dr. Steven Vogl of the Montefiore Medical Center in the Bronx, New York, asked about pathologic complete response (pCR).

"We did not require any specific degree of response for the patients to be in the study, since all of the patients were getting a completion ALND," Dr. Boughey replied. "We are currently evaluating specifically that question about whether the breast response and/or the nodal response on ultrasound can help define the appropriate patient population for us to tailor this therapy to."

Dr. Vogl noted that for patients who are HER2-positive, ER-negative, and triple-negative, pCR is very important. "So if we can figure out very carefully who didn’t achieve a pCR, especially in the node, we can probably do something for those patients some day with the right agents," he said.

"Do you use clips in all patients? Do you use dual agents always? And do you always remove two sentinel nodes? What is the impact of this on what we should do next?" asked session moderator Dr. Anthony Lucci Jr., of the University of Texas M.D. Anderson Cancer Center in Houston.

Dr. Boughey replied, "The take-home message is ... I’ll be looking at clip placement, making sure that we use dual-agent tracer for these cases, and ensuring that we do a thorough evaluation of the axilla and resecting any node that is radioactive, blue, or palpable.

"One of the concerns always when you are doing the sentinel node and you know you are doing a planned dissection [thereafter] is that the completeness of the evaluation of the axilla may not be quite as thorough as if you are closing as soon as you finish that sentinel node biopsy. So I think that is where the onus rests on the surgeon, so that we thoroughly evaluate the axilla and ensure this technique is as thorough as possible," she added.

In an additional analysis of patients with clinical N2 disease, the false-negative rate of SLN was 0%.

"Further work is under way regarding the secondary endpoint of this study, which will look at correlating the axillary ultrasound after chemotherapy with the false-negative rate. ... Maybe this can help improve patient selection for the procedure and further lower the false-negative rate," Dr. Boughey said. "We are also continuing to work to evaluate lymphedema rates and quality of life in these patients."

Dr. Boughey disclosed no relevant conflicts of interest.

SAN ANTONIO – A lower-dose, briefer radiotherapy regimen than is standard for early-stage breast cancer in the U.S. demonstrated comparable efficacy with fewer side effects at 10 years of follow-up in a pair of landmark U.K. studies.

"Long-term follow-up confirms that a lower total dose of radiation in fewer, slightly larger fractions delivered over a shorter treatment time is at least as safe and effective as standard 5-week schedules of curative radiotherapy in women with early breast cancer," Dr. John R. Yarnold declared in presenting the latest data from the U.K. START (Standardization of Breast Radiotherapy) trials at the annual San Antonio Breast Cancer Symposium.

The historical standard of care for radiotherapy in patients with surgically excised early breast cancer is 50 Gy delivered in 25 fractions of 2.0 Gy each over the course of 5 weeks. That’s still standard practice in the United States.

In the United Kingdom, however, the standard nationwide is 40 Gy in 15 fractions of 2.67 Gy over 3 weeks. Radiologists term this "hypofractionation": delivering a lower total dose of radiation using fewer but larger fractions. Hypofractionation has standard practice in the United Kingdom since the National Institute for Health and Clinical Excellence–issued guidelines to that effect in 2009. Those guidelines were based in large part on the earlier, highly favorable 5-year outcomes of START A (Lancet Oncology 2008;9:331-41) and START B (Lancet 2008;371:1098-107).

The START investigators deemed it essential to conduct the new 10-year analysis because adverse effects of radiotherapy given for breast cancer can arise after the 5-year mark. Also, it was important to learn whether the early antitumor effects of hypofractionated radiotherapy persisted, explained Dr. Yarnold, professor of clinical oncology at the Institute of Cancer Research, London.

The two key findings at the 10-year mark of START are, first, that both breast cancer and the dose-limiting normal tissues respond similarly to fraction size, so there’s no advantage in continuing the 2 Gy fractions that have historically been the international standard; and, second, that a 15-fraction/3-week schedule is gentler on normal tissues and comparable in antitumor efficacy to a 25-fraction/5-week regimen.

The clinical implications are clear, Dr. Yarnold emphasized: "Patients can safely be treated to a lower total dose with fewer fractions than the historical standard of 50 Gy and 25 fractions. There are no detrimental effects of hypofractionation noted in any of the subgroups studied."

The 10-year rate of moderate to marked adverse treatment effects on normal tissues in START A survivors who received 39 Gy in 13 fractions over 5 weeks was 43.9% compared with 50.4% in those randomized to 50 Gy in 25 fractions over 5 weeks. The resultant 20% relative risk reduction with a lower total radiation dose delivered in fewer fractions was statistically significant. In contrast, the 10-year locoregional tumor relapse rates in the two groups were similarly low.

At 10 years in START B, patients who received 40 Gy in 15 fractions over 3 weeks had a 37.9% rate of moderate-to-marked adverse effects on normal tissues, compared with a 45.3% rate in those who got 50 Gy in 25 fractions over 5 weeks, for a highly significant 23% risk reduction. The relapse rate was 4.3% after 40 Gy and 5.5% after 50 Gy, a nonsignificant difference.

In both trials, all types of side effects involving normal tissues were significantly less common in the lower-total-dose, fewer-fraction groups. That includes brachial plexus injury, which has been a concern expressed by supporters of the historical standard regimen, Dr. Yarnold added.

Radiologists and surgeons in the audience called the 10-year START results "very, very important" and likely to be practice changing.

Canada has already switched from the historical standard to 42.5 Gy delivered in 16 fractions over the course of 22 days. Asked if he thinks U.S. radiologists, too, should change their practice in light of the START findings, Dr. Yarnold was diplomatic. "I foresee no scientific reasons why they should not consider that very carefully," he replied.

Follow-up will continue in the START trials, which are funded by the Institute for Cancer Research, Cancer Research UK, the Medical Research Council, and the National Cancer Research Institute. Dr. Yarnold reported having no financial conflicts.

[email protected]

SAN ANTONIO – A lower-dose, briefer radiotherapy regimen than is standard for early-stage breast cancer in the U.S. demonstrated comparable efficacy with fewer side effects at 10 years of follow-up in a pair of landmark U.K. studies.

"Long-term follow-up confirms that a lower total dose of radiation in fewer, slightly larger fractions delivered over a shorter treatment time is at least as safe and effective as standard 5-week schedules of curative radiotherapy in women with early breast cancer," Dr. John R. Yarnold declared in presenting the latest data from the U.K. START (Standardization of Breast Radiotherapy) trials at the annual San Antonio Breast Cancer Symposium.

The historical standard of care for radiotherapy in patients with surgically excised early breast cancer is 50 Gy delivered in 25 fractions of 2.0 Gy each over the course of 5 weeks. That’s still standard practice in the United States.

In the United Kingdom, however, the standard nationwide is 40 Gy in 15 fractions of 2.67 Gy over 3 weeks. Radiologists term this "hypofractionation": delivering a lower total dose of radiation using fewer but larger fractions. Hypofractionation has standard practice in the United Kingdom since the National Institute for Health and Clinical Excellence–issued guidelines to that effect in 2009. Those guidelines were based in large part on the earlier, highly favorable 5-year outcomes of START A (Lancet Oncology 2008;9:331-41) and START B (Lancet 2008;371:1098-107).

The START investigators deemed it essential to conduct the new 10-year analysis because adverse effects of radiotherapy given for breast cancer can arise after the 5-year mark. Also, it was important to learn whether the early antitumor effects of hypofractionated radiotherapy persisted, explained Dr. Yarnold, professor of clinical oncology at the Institute of Cancer Research, London.

The two key findings at the 10-year mark of START are, first, that both breast cancer and the dose-limiting normal tissues respond similarly to fraction size, so there’s no advantage in continuing the 2 Gy fractions that have historically been the international standard; and, second, that a 15-fraction/3-week schedule is gentler on normal tissues and comparable in antitumor efficacy to a 25-fraction/5-week regimen.

The clinical implications are clear, Dr. Yarnold emphasized: "Patients can safely be treated to a lower total dose with fewer fractions than the historical standard of 50 Gy and 25 fractions. There are no detrimental effects of hypofractionation noted in any of the subgroups studied."

The 10-year rate of moderate to marked adverse treatment effects on normal tissues in START A survivors who received 39 Gy in 13 fractions over 5 weeks was 43.9% compared with 50.4% in those randomized to 50 Gy in 25 fractions over 5 weeks. The resultant 20% relative risk reduction with a lower total radiation dose delivered in fewer fractions was statistically significant. In contrast, the 10-year locoregional tumor relapse rates in the two groups were similarly low.

At 10 years in START B, patients who received 40 Gy in 15 fractions over 3 weeks had a 37.9% rate of moderate-to-marked adverse effects on normal tissues, compared with a 45.3% rate in those who got 50 Gy in 25 fractions over 5 weeks, for a highly significant 23% risk reduction. The relapse rate was 4.3% after 40 Gy and 5.5% after 50 Gy, a nonsignificant difference.

In both trials, all types of side effects involving normal tissues were significantly less common in the lower-total-dose, fewer-fraction groups. That includes brachial plexus injury, which has been a concern expressed by supporters of the historical standard regimen, Dr. Yarnold added.

Radiologists and surgeons in the audience called the 10-year START results "very, very important" and likely to be practice changing.

Canada has already switched from the historical standard to 42.5 Gy delivered in 16 fractions over the course of 22 days. Asked if he thinks U.S. radiologists, too, should change their practice in light of the START findings, Dr. Yarnold was diplomatic. "I foresee no scientific reasons why they should not consider that very carefully," he replied.

Follow-up will continue in the START trials, which are funded by the Institute for Cancer Research, Cancer Research UK, the Medical Research Council, and the National Cancer Research Institute. Dr. Yarnold reported having no financial conflicts.

[email protected]

SAN ANTONIO – A lower-dose, briefer radiotherapy regimen than is standard for early-stage breast cancer in the U.S. demonstrated comparable efficacy with fewer side effects at 10 years of follow-up in a pair of landmark U.K. studies.

"Long-term follow-up confirms that a lower total dose of radiation in fewer, slightly larger fractions delivered over a shorter treatment time is at least as safe and effective as standard 5-week schedules of curative radiotherapy in women with early breast cancer," Dr. John R. Yarnold declared in presenting the latest data from the U.K. START (Standardization of Breast Radiotherapy) trials at the annual San Antonio Breast Cancer Symposium.

The historical standard of care for radiotherapy in patients with surgically excised early breast cancer is 50 Gy delivered in 25 fractions of 2.0 Gy each over the course of 5 weeks. That’s still standard practice in the United States.

In the United Kingdom, however, the standard nationwide is 40 Gy in 15 fractions of 2.67 Gy over 3 weeks. Radiologists term this "hypofractionation": delivering a lower total dose of radiation using fewer but larger fractions. Hypofractionation has standard practice in the United Kingdom since the National Institute for Health and Clinical Excellence–issued guidelines to that effect in 2009. Those guidelines were based in large part on the earlier, highly favorable 5-year outcomes of START A (Lancet Oncology 2008;9:331-41) and START B (Lancet 2008;371:1098-107).

The START investigators deemed it essential to conduct the new 10-year analysis because adverse effects of radiotherapy given for breast cancer can arise after the 5-year mark. Also, it was important to learn whether the early antitumor effects of hypofractionated radiotherapy persisted, explained Dr. Yarnold, professor of clinical oncology at the Institute of Cancer Research, London.

The two key findings at the 10-year mark of START are, first, that both breast cancer and the dose-limiting normal tissues respond similarly to fraction size, so there’s no advantage in continuing the 2 Gy fractions that have historically been the international standard; and, second, that a 15-fraction/3-week schedule is gentler on normal tissues and comparable in antitumor efficacy to a 25-fraction/5-week regimen.

The clinical implications are clear, Dr. Yarnold emphasized: "Patients can safely be treated to a lower total dose with fewer fractions than the historical standard of 50 Gy and 25 fractions. There are no detrimental effects of hypofractionation noted in any of the subgroups studied."

The 10-year rate of moderate to marked adverse treatment effects on normal tissues in START A survivors who received 39 Gy in 13 fractions over 5 weeks was 43.9% compared with 50.4% in those randomized to 50 Gy in 25 fractions over 5 weeks. The resultant 20% relative risk reduction with a lower total radiation dose delivered in fewer fractions was statistically significant. In contrast, the 10-year locoregional tumor relapse rates in the two groups were similarly low.

At 10 years in START B, patients who received 40 Gy in 15 fractions over 3 weeks had a 37.9% rate of moderate-to-marked adverse effects on normal tissues, compared with a 45.3% rate in those who got 50 Gy in 25 fractions over 5 weeks, for a highly significant 23% risk reduction. The relapse rate was 4.3% after 40 Gy and 5.5% after 50 Gy, a nonsignificant difference.

In both trials, all types of side effects involving normal tissues were significantly less common in the lower-total-dose, fewer-fraction groups. That includes brachial plexus injury, which has been a concern expressed by supporters of the historical standard regimen, Dr. Yarnold added.

Radiologists and surgeons in the audience called the 10-year START results "very, very important" and likely to be practice changing.

Canada has already switched from the historical standard to 42.5 Gy delivered in 16 fractions over the course of 22 days. Asked if he thinks U.S. radiologists, too, should change their practice in light of the START findings, Dr. Yarnold was diplomatic. "I foresee no scientific reasons why they should not consider that very carefully," he replied.

Follow-up will continue in the START trials, which are funded by the Institute for Cancer Research, Cancer Research UK, the Medical Research Council, and the National Cancer Research Institute. Dr. Yarnold reported having no financial conflicts.

[email protected]

SAN ANTONIO – Adjuvant chemotherapy in women with completely resected locoregional recurrence of breast cancer improved disease-free and overall survival in the randomized CALOR trial.

Indeed, adjuvant chemotherapy reduced the risk of recurrent disease by 41% during 5 years of follow-up in CALOR (Chemotherapy as Adjuvant for Locally Recurrent Breast Cancer) while cutting the risk of all-cause mortality by 59%, Dr. Stefan Aebi reported at the annual San Antonio Breast Cancer Symposium.

Thus, CALOR helps resolve a longstanding controversy regarding the appropriate treatment of patients with isolated local or regional recurrence of breast cancer. But the trial provides only a partial resolution. That’s because while adjuvant chemotherapy had a huge benefit in patients with estrogen receptor–negative locoregional recurrences, in estrogen receptor–positive recurrences it had no significant effect.

"Decisions regarding ER-positive recurrent tumors remain a struggle. But events are very few so far. We consider this analysis premature. We will need longer follow-up for patients with ER-positive recurrences to see if there is a benefit for chemotherapy," said Dr. Aebi, head of the division of medical oncology at Lucerne Canton Hospital in Switzerland.

CALOR included 162 patients with isolated local and/or regional recurrence of breast cancer. After complete excisional surgery, they were randomized to chemotherapy or no chemotherapy. The choice of chemotherapy regimen was left to the patient’s oncologists, with a recommendation from CALOR investigators to use at least two drugs for 3-6 months. Radiation therapy was recommended for all patients, but only about 40% received it.

The 5-year disease-free survival rate – the primary endpoint – was 69% in the chemotherapy group compared with 57% with no adjuvant chemotherapy. This translates to a 41% relative risk reduction (P = .045). The 5-year overall survival rate was 88% in the chemotherapy group vs. 76% in controls, for a 59% reduction in risk (P = .02).

These benefits were driven by the outstanding effectiveness of chemotherapy in patients with ER-negative recurrences. Their 5-year disease-free survival rate was 67% with adjuvant chemotherapy compared with 35% without it, for a 68% reduction in risk (P = .007). Overall survival in the ER-negative recurrence subgroup was 79% with chemotherapy and 69% without. In contrast, the 5-year disease-free survival rate in the ER-positive group was 70% with chemotherapy and 69% without.

In a multivariate analysis controlling for ER status, location of the isolated recurrence, and prior chemotherapy, adjunctive chemotherapy was associated with a 50% reduction in recurrent disease during 5 years of follow-up (P = .01). The only other independent predictor of disease-free survival was time since primary surgery: The risk of recurrent disease during 5 years of follow-up dropped by 9% for each year since primary surgery.

This was a difficult study to conduct. The original plans called for recruitment of nearly 1,000 patients, but enrollment was so slow that Dr. Aebi and coinvestigators had to scale back their ambitions, eventually closing the trial with 162 participants.

"There were many colleagues with preconceived ideas. We had colleagues who just knew that chemotherapy was not needed and others who just knew that it was needed. And if you know, why should you randomize your patients?" he explained.

Dr. Carlos L. Arteaga called CALOR "a very important contribution to what has been an ongoing controversy in this field."

"Some surgeons feel very strongly that resection is enough in treating local recurrences, while many of our medical oncologists feel chemotherapy is also required. I have a lot more impetus to give adjuvant chemotherapy based on the CALOR findings," said Dr. Arteaga, director of the breast cancer program at Vanderbilt-Ingram Cancer Center, Nashville, Tenn.

The CALOR trial was sponsored by several major cancer research organizations. Dr. Aebi reported having no financial conflicts.

SAN ANTONIO – Adjuvant chemotherapy in women with completely resected locoregional recurrence of breast cancer improved disease-free and overall survival in the randomized CALOR trial.

Indeed, adjuvant chemotherapy reduced the risk of recurrent disease by 41% during 5 years of follow-up in CALOR (Chemotherapy as Adjuvant for Locally Recurrent Breast Cancer) while cutting the risk of all-cause mortality by 59%, Dr. Stefan Aebi reported at the annual San Antonio Breast Cancer Symposium.

Thus, CALOR helps resolve a longstanding controversy regarding the appropriate treatment of patients with isolated local or regional recurrence of breast cancer. But the trial provides only a partial resolution. That’s because while adjuvant chemotherapy had a huge benefit in patients with estrogen receptor–negative locoregional recurrences, in estrogen receptor–positive recurrences it had no significant effect.

"Decisions regarding ER-positive recurrent tumors remain a struggle. But events are very few so far. We consider this analysis premature. We will need longer follow-up for patients with ER-positive recurrences to see if there is a benefit for chemotherapy," said Dr. Aebi, head of the division of medical oncology at Lucerne Canton Hospital in Switzerland.

CALOR included 162 patients with isolated local and/or regional recurrence of breast cancer. After complete excisional surgery, they were randomized to chemotherapy or no chemotherapy. The choice of chemotherapy regimen was left to the patient’s oncologists, with a recommendation from CALOR investigators to use at least two drugs for 3-6 months. Radiation therapy was recommended for all patients, but only about 40% received it.

The 5-year disease-free survival rate – the primary endpoint – was 69% in the chemotherapy group compared with 57% with no adjuvant chemotherapy. This translates to a 41% relative risk reduction (P = .045). The 5-year overall survival rate was 88% in the chemotherapy group vs. 76% in controls, for a 59% reduction in risk (P = .02).

These benefits were driven by the outstanding effectiveness of chemotherapy in patients with ER-negative recurrences. Their 5-year disease-free survival rate was 67% with adjuvant chemotherapy compared with 35% without it, for a 68% reduction in risk (P = .007). Overall survival in the ER-negative recurrence subgroup was 79% with chemotherapy and 69% without. In contrast, the 5-year disease-free survival rate in the ER-positive group was 70% with chemotherapy and 69% without.

In a multivariate analysis controlling for ER status, location of the isolated recurrence, and prior chemotherapy, adjunctive chemotherapy was associated with a 50% reduction in recurrent disease during 5 years of follow-up (P = .01). The only other independent predictor of disease-free survival was time since primary surgery: The risk of recurrent disease during 5 years of follow-up dropped by 9% for each year since primary surgery.

This was a difficult study to conduct. The original plans called for recruitment of nearly 1,000 patients, but enrollment was so slow that Dr. Aebi and coinvestigators had to scale back their ambitions, eventually closing the trial with 162 participants.

"There were many colleagues with preconceived ideas. We had colleagues who just knew that chemotherapy was not needed and others who just knew that it was needed. And if you know, why should you randomize your patients?" he explained.

Dr. Carlos L. Arteaga called CALOR "a very important contribution to what has been an ongoing controversy in this field."

"Some surgeons feel very strongly that resection is enough in treating local recurrences, while many of our medical oncologists feel chemotherapy is also required. I have a lot more impetus to give adjuvant chemotherapy based on the CALOR findings," said Dr. Arteaga, director of the breast cancer program at Vanderbilt-Ingram Cancer Center, Nashville, Tenn.

The CALOR trial was sponsored by several major cancer research organizations. Dr. Aebi reported having no financial conflicts.

SAN ANTONIO – Adjuvant chemotherapy in women with completely resected locoregional recurrence of breast cancer improved disease-free and overall survival in the randomized CALOR trial.

Indeed, adjuvant chemotherapy reduced the risk of recurrent disease by 41% during 5 years of follow-up in CALOR (Chemotherapy as Adjuvant for Locally Recurrent Breast Cancer) while cutting the risk of all-cause mortality by 59%, Dr. Stefan Aebi reported at the annual San Antonio Breast Cancer Symposium.

Thus, CALOR helps resolve a longstanding controversy regarding the appropriate treatment of patients with isolated local or regional recurrence of breast cancer. But the trial provides only a partial resolution. That’s because while adjuvant chemotherapy had a huge benefit in patients with estrogen receptor–negative locoregional recurrences, in estrogen receptor–positive recurrences it had no significant effect.

"Decisions regarding ER-positive recurrent tumors remain a struggle. But events are very few so far. We consider this analysis premature. We will need longer follow-up for patients with ER-positive recurrences to see if there is a benefit for chemotherapy," said Dr. Aebi, head of the division of medical oncology at Lucerne Canton Hospital in Switzerland.

CALOR included 162 patients with isolated local and/or regional recurrence of breast cancer. After complete excisional surgery, they were randomized to chemotherapy or no chemotherapy. The choice of chemotherapy regimen was left to the patient’s oncologists, with a recommendation from CALOR investigators to use at least two drugs for 3-6 months. Radiation therapy was recommended for all patients, but only about 40% received it.

The 5-year disease-free survival rate – the primary endpoint – was 69% in the chemotherapy group compared with 57% with no adjuvant chemotherapy. This translates to a 41% relative risk reduction (P = .045). The 5-year overall survival rate was 88% in the chemotherapy group vs. 76% in controls, for a 59% reduction in risk (P = .02).

These benefits were driven by the outstanding effectiveness of chemotherapy in patients with ER-negative recurrences. Their 5-year disease-free survival rate was 67% with adjuvant chemotherapy compared with 35% without it, for a 68% reduction in risk (P = .007). Overall survival in the ER-negative recurrence subgroup was 79% with chemotherapy and 69% without. In contrast, the 5-year disease-free survival rate in the ER-positive group was 70% with chemotherapy and 69% without.

In a multivariate analysis controlling for ER status, location of the isolated recurrence, and prior chemotherapy, adjunctive chemotherapy was associated with a 50% reduction in recurrent disease during 5 years of follow-up (P = .01). The only other independent predictor of disease-free survival was time since primary surgery: The risk of recurrent disease during 5 years of follow-up dropped by 9% for each year since primary surgery.

This was a difficult study to conduct. The original plans called for recruitment of nearly 1,000 patients, but enrollment was so slow that Dr. Aebi and coinvestigators had to scale back their ambitions, eventually closing the trial with 162 participants.

"There were many colleagues with preconceived ideas. We had colleagues who just knew that chemotherapy was not needed and others who just knew that it was needed. And if you know, why should you randomize your patients?" he explained.

Dr. Carlos L. Arteaga called CALOR "a very important contribution to what has been an ongoing controversy in this field."

"Some surgeons feel very strongly that resection is enough in treating local recurrences, while many of our medical oncologists feel chemotherapy is also required. I have a lot more impetus to give adjuvant chemotherapy based on the CALOR findings," said Dr. Arteaga, director of the breast cancer program at Vanderbilt-Ingram Cancer Center, Nashville, Tenn.

The CALOR trial was sponsored by several major cancer research organizations. Dr. Aebi reported having no financial conflicts.

SAN ANTONIO – The 10-year incidence of leukemia after adjuvant chemotherapy for breast cancer appears to hover around 0.5%, twice as high as previously reported.

A review of more than 20,000 patient records included in the National Comprehensive Cancer Network (NCCN) database found 51 cases of leukemia that developed within 10 years of treatment. Women who had only chemotherapy were at the greatest risk – almost six times more likely to develop the disease than the surgery-only control group, Dr. Antonio Wolff said at that annual San Antonio Breast Cancer Symposium.

"We know that the observed survival benefit with adjuvant therapy does take into account the potential mortality associated with leukemia," said Dr. Wolff of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore. "But often we are in the situation where we make the decision to give chemotherapy ‘just because.’ We need to be very careful here, because some of those patients will potentially derive none of the benefits of chemo, and be at risk of its toxicities."

Dr. Wolff and colleagues examined the 1997-2008 data from eight facilities in the NCCN database – a total of 20,533 women with a first diagnosis of breast cancer. The median follow-up was 5 years, but some data were available for up to 15 years after treatment.

About half of the cohort had stage I disease; in most, the cancer was invasive ductal. Slightly more than half had hormone receptor–positive/HER2 negative disease.

The only baseline characteristic significantly different between the groups was age. Women who developed leukemia were significantly older at the time of their cancer treatment (60 vs. 54 years; P = .02); 78% of those with leukemia were older than 50 years.

Of the 51 cases, 44 were acute myeloid leukemia (AML), with a median onset time of 3.5 years after treatment. One-third of these occurred in women with a family history of breast or ovarian cancer. The median time to onset in the AML cases was 2 years.

None of the tumor characteristics were significantly associated with the development of leukemia. There were no significant differences among those who had breast-conserving surgery, mastectomy, or no surgery; or between those who had no radiation therapy, radiation without surgery, radiation after breast-conserving surgery, or radiation after mastectomy, though larger numbers of patients are needed for some of these smaller subset analyses.

The overall rate of leukemia per 1,000 patient/years was 0.46; in the surgery-only group, the rate was 0.16 per 1,000 patient-years. "Of interest is that the rates in each of the treatment groups were similar to the overall rate," – 0.43 in the radiation-only group, 0.52 in the chemotherapy-only group, and 0.54 in the combination therapy group.

At 5 years, the cumulative incidence of leukemia was 0.05% in the surgery-only group; 0.19% in the radiation-only group; 0.30% in the chemotherapy-only group; and 0.32% in the combination therapy group.

But the onset accelerated over the study period, Dr. Wolff noted, with the bulk of cases developing from years 6 to 10. .By the end of the 10-year period, the incidence was 0.2% in the surgery-only group; 0.44% in the radiation-only group; 0.52% in the chemotherapy group; and 0.51% in the combination group.

In a risk analysis using surgery as the control, the overall hazard ratio of leukemia was 2.7 in the radiation-only group; 5.68 in the chemotherapy only group; and 5.64 in the combination group.

Radiation appeared to confer no significant additional risk when it was combined with chemotherapy, Dr. Wolff added.

The findings are strikingly different than previously identified. The largest study of the association was published in 2003, when researchers from the National Surgical Adjuvant Breast and Bowel Project Operations Center reviewed six trials that examined rates of acute myeloid leukemia and myelodysplastic syndrome after doxorubicin and cyclophosphamide therapy (Clin. Breast Cancer 2003;4:273-9).

The subgroup that received anthracycline/cyclophosphamide in that review had a cumulative 8-year incidence of 0.24%. In Dr. Wolff’s chemotherapy subgroup, the cumulative 8-year incidence was 0.52%.

"It’s very important to keep in mind that the known leukemia latency period for anthracycline is 1-3 years, but that of alkylating drugs like cyclophosphamide is 4-6 years and there are case reports of it developing after 10 years," he said. "We need to be very careful when we talk about survival at 5 years vs. 10 years in exposed patients, because they could be at risk for a decade and, potentially, even longer."

SAN ANTONIO – The 10-year incidence of leukemia after adjuvant chemotherapy for breast cancer appears to hover around 0.5%, twice as high as previously reported.

A review of more than 20,000 patient records included in the National Comprehensive Cancer Network (NCCN) database found 51 cases of leukemia that developed within 10 years of treatment. Women who had only chemotherapy were at the greatest risk – almost six times more likely to develop the disease than the surgery-only control group, Dr. Antonio Wolff said at that annual San Antonio Breast Cancer Symposium.

"We know that the observed survival benefit with adjuvant therapy does take into account the potential mortality associated with leukemia," said Dr. Wolff of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore. "But often we are in the situation where we make the decision to give chemotherapy ‘just because.’ We need to be very careful here, because some of those patients will potentially derive none of the benefits of chemo, and be at risk of its toxicities."

Dr. Wolff and colleagues examined the 1997-2008 data from eight facilities in the NCCN database – a total of 20,533 women with a first diagnosis of breast cancer. The median follow-up was 5 years, but some data were available for up to 15 years after treatment.

About half of the cohort had stage I disease; in most, the cancer was invasive ductal. Slightly more than half had hormone receptor–positive/HER2 negative disease.

The only baseline characteristic significantly different between the groups was age. Women who developed leukemia were significantly older at the time of their cancer treatment (60 vs. 54 years; P = .02); 78% of those with leukemia were older than 50 years.

Of the 51 cases, 44 were acute myeloid leukemia (AML), with a median onset time of 3.5 years after treatment. One-third of these occurred in women with a family history of breast or ovarian cancer. The median time to onset in the AML cases was 2 years.

None of the tumor characteristics were significantly associated with the development of leukemia. There were no significant differences among those who had breast-conserving surgery, mastectomy, or no surgery; or between those who had no radiation therapy, radiation without surgery, radiation after breast-conserving surgery, or radiation after mastectomy, though larger numbers of patients are needed for some of these smaller subset analyses.

The overall rate of leukemia per 1,000 patient/years was 0.46; in the surgery-only group, the rate was 0.16 per 1,000 patient-years. "Of interest is that the rates in each of the treatment groups were similar to the overall rate," – 0.43 in the radiation-only group, 0.52 in the chemotherapy-only group, and 0.54 in the combination therapy group.

At 5 years, the cumulative incidence of leukemia was 0.05% in the surgery-only group; 0.19% in the radiation-only group; 0.30% in the chemotherapy-only group; and 0.32% in the combination therapy group.

But the onset accelerated over the study period, Dr. Wolff noted, with the bulk of cases developing from years 6 to 10. .By the end of the 10-year period, the incidence was 0.2% in the surgery-only group; 0.44% in the radiation-only group; 0.52% in the chemotherapy group; and 0.51% in the combination group.

In a risk analysis using surgery as the control, the overall hazard ratio of leukemia was 2.7 in the radiation-only group; 5.68 in the chemotherapy only group; and 5.64 in the combination group.

Radiation appeared to confer no significant additional risk when it was combined with chemotherapy, Dr. Wolff added.

The findings are strikingly different than previously identified. The largest study of the association was published in 2003, when researchers from the National Surgical Adjuvant Breast and Bowel Project Operations Center reviewed six trials that examined rates of acute myeloid leukemia and myelodysplastic syndrome after doxorubicin and cyclophosphamide therapy (Clin. Breast Cancer 2003;4:273-9).

The subgroup that received anthracycline/cyclophosphamide in that review had a cumulative 8-year incidence of 0.24%. In Dr. Wolff’s chemotherapy subgroup, the cumulative 8-year incidence was 0.52%.

"It’s very important to keep in mind that the known leukemia latency period for anthracycline is 1-3 years, but that of alkylating drugs like cyclophosphamide is 4-6 years and there are case reports of it developing after 10 years," he said. "We need to be very careful when we talk about survival at 5 years vs. 10 years in exposed patients, because they could be at risk for a decade and, potentially, even longer."

SAN ANTONIO – The 10-year incidence of leukemia after adjuvant chemotherapy for breast cancer appears to hover around 0.5%, twice as high as previously reported.

A review of more than 20,000 patient records included in the National Comprehensive Cancer Network (NCCN) database found 51 cases of leukemia that developed within 10 years of treatment. Women who had only chemotherapy were at the greatest risk – almost six times more likely to develop the disease than the surgery-only control group, Dr. Antonio Wolff said at that annual San Antonio Breast Cancer Symposium.

"We know that the observed survival benefit with adjuvant therapy does take into account the potential mortality associated with leukemia," said Dr. Wolff of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore. "But often we are in the situation where we make the decision to give chemotherapy ‘just because.’ We need to be very careful here, because some of those patients will potentially derive none of the benefits of chemo, and be at risk of its toxicities."

Dr. Wolff and colleagues examined the 1997-2008 data from eight facilities in the NCCN database – a total of 20,533 women with a first diagnosis of breast cancer. The median follow-up was 5 years, but some data were available for up to 15 years after treatment.

About half of the cohort had stage I disease; in most, the cancer was invasive ductal. Slightly more than half had hormone receptor–positive/HER2 negative disease.

The only baseline characteristic significantly different between the groups was age. Women who developed leukemia were significantly older at the time of their cancer treatment (60 vs. 54 years; P = .02); 78% of those with leukemia were older than 50 years.

Of the 51 cases, 44 were acute myeloid leukemia (AML), with a median onset time of 3.5 years after treatment. One-third of these occurred in women with a family history of breast or ovarian cancer. The median time to onset in the AML cases was 2 years.

None of the tumor characteristics were significantly associated with the development of leukemia. There were no significant differences among those who had breast-conserving surgery, mastectomy, or no surgery; or between those who had no radiation therapy, radiation without surgery, radiation after breast-conserving surgery, or radiation after mastectomy, though larger numbers of patients are needed for some of these smaller subset analyses.

The overall rate of leukemia per 1,000 patient/years was 0.46; in the surgery-only group, the rate was 0.16 per 1,000 patient-years. "Of interest is that the rates in each of the treatment groups were similar to the overall rate," – 0.43 in the radiation-only group, 0.52 in the chemotherapy-only group, and 0.54 in the combination therapy group.

At 5 years, the cumulative incidence of leukemia was 0.05% in the surgery-only group; 0.19% in the radiation-only group; 0.30% in the chemotherapy-only group; and 0.32% in the combination therapy group.

But the onset accelerated over the study period, Dr. Wolff noted, with the bulk of cases developing from years 6 to 10. .By the end of the 10-year period, the incidence was 0.2% in the surgery-only group; 0.44% in the radiation-only group; 0.52% in the chemotherapy group; and 0.51% in the combination group.

In a risk analysis using surgery as the control, the overall hazard ratio of leukemia was 2.7 in the radiation-only group; 5.68 in the chemotherapy only group; and 5.64 in the combination group.

Radiation appeared to confer no significant additional risk when it was combined with chemotherapy, Dr. Wolff added.

The findings are strikingly different than previously identified. The largest study of the association was published in 2003, when researchers from the National Surgical Adjuvant Breast and Bowel Project Operations Center reviewed six trials that examined rates of acute myeloid leukemia and myelodysplastic syndrome after doxorubicin and cyclophosphamide therapy (Clin. Breast Cancer 2003;4:273-9).

The subgroup that received anthracycline/cyclophosphamide in that review had a cumulative 8-year incidence of 0.24%. In Dr. Wolff’s chemotherapy subgroup, the cumulative 8-year incidence was 0.52%.

"It’s very important to keep in mind that the known leukemia latency period for anthracycline is 1-3 years, but that of alkylating drugs like cyclophosphamide is 4-6 years and there are case reports of it developing after 10 years," he said. "We need to be very careful when we talk about survival at 5 years vs. 10 years in exposed patients, because they could be at risk for a decade and, potentially, even longer."

SAN ANTONIO – Black women are significantly less likely to receive a sentinel lymph node biopsy than are white women – and significantly more likely to develop lymphedema, a large database study has determined.

Among more than 31,000 women with invasive breast cancer diagnosed from 2002-2007, 62% of black women underwent the procedure, compared with 74% of white women – a significant difference (P less than .001).

That disparity led to a doubling in the risk of lymphedema in black women, compared with white women, Dr. Dalliah Black said at the San Antonio Breast Cancer Symposium. Axillary sentinel lymph node biopsy (SLNB) is a less-invasive alternative to axillary lymph node dissection (ALND) for breast cancer staging.

The disparity appears to be regional, said Dr. Black of the University of Texas M.D. Anderson Cancer Center in Houston. A preliminary subanalysis of 12 regions in the database found that Louisiana had the lowest rate of sentinel node biopsy among blacks (58%), while Seattle had the highest (89%). Regional differences were related not only to the patient’s socioeconomic status but to the numbers of surgeons available in the region.

Dr. Black used data extracted from the U.S. national Surveillance, Epidemiology, and End Results (SEER) database. The patient group consisted of 31,274 women diagnosed between 2002 and 2007. All patients had invasive breast cancer with no evidence of distant metastasis and underwent a documented axillary surgical procedure. All of the patients had fee-for-service coverage.

Black women composed 6% of the group (1,767). The median age was 74 years; 75% of the patients had a tumor size of 2 cm or smaller. Most (62%) had undergone a lumpectomy, and 73%, a sentinel lymph node biopsy.

The median number of sentinel nodes removed was two, and the median number of axillary nodes, 11.

The rate of sentinel node biopsy increased in both groups over the study period, as the surgery moved from being an alternate management approach to the preferred approach. But the disparity persisted, Dr. Black said. By 2007, the biopsy rate was 70% among black women and 83% among white (P less than .001).

The difference in SLND was also associated with a significantly increased rate of lymphedema. By 5 years after surgery, lymphedema had developed in 18% of black women who had an axillary node biopsy compared with 7% of white women who had a sentinel node biopsy. But when black women had a sentinel node biopsy, their 5-year rate of lymphedema was similar to the rate among white women (9%; P less than .001).

"This shows that if black women had gotten the appropriate surgery, they were not at any increased risk for lymphedema," Dr. Black said.

She intends to reanalyze the groups when the 2010 SEER data is released next spring. "We hope to see the disparity reduced in that analysis, although it may not be," she said in an interview. "If it’s not, we really need to figure out how we can work with national programs to disseminate guidelines and provide reminders to surgeons and multispecialist breast cancer teams – as well as to patients, so they can advocate for themselves. But it’s not only the patient’s responsibility. It’s a two-way street. We need to take some responsibility for this problem."

Dr. Black has no relevant financial relationships to disclose.

SAN ANTONIO – Black women are significantly less likely to receive a sentinel lymph node biopsy than are white women – and significantly more likely to develop lymphedema, a large database study has determined.

Among more than 31,000 women with invasive breast cancer diagnosed from 2002-2007, 62% of black women underwent the procedure, compared with 74% of white women – a significant difference (P less than .001).

That disparity led to a doubling in the risk of lymphedema in black women, compared with white women, Dr. Dalliah Black said at the San Antonio Breast Cancer Symposium. Axillary sentinel lymph node biopsy (SLNB) is a less-invasive alternative to axillary lymph node dissection (ALND) for breast cancer staging.

The disparity appears to be regional, said Dr. Black of the University of Texas M.D. Anderson Cancer Center in Houston. A preliminary subanalysis of 12 regions in the database found that Louisiana had the lowest rate of sentinel node biopsy among blacks (58%), while Seattle had the highest (89%). Regional differences were related not only to the patient’s socioeconomic status but to the numbers of surgeons available in the region.

Dr. Black used data extracted from the U.S. national Surveillance, Epidemiology, and End Results (SEER) database. The patient group consisted of 31,274 women diagnosed between 2002 and 2007. All patients had invasive breast cancer with no evidence of distant metastasis and underwent a documented axillary surgical procedure. All of the patients had fee-for-service coverage.

Black women composed 6% of the group (1,767). The median age was 74 years; 75% of the patients had a tumor size of 2 cm or smaller. Most (62%) had undergone a lumpectomy, and 73%, a sentinel lymph node biopsy.

The median number of sentinel nodes removed was two, and the median number of axillary nodes, 11.

The rate of sentinel node biopsy increased in both groups over the study period, as the surgery moved from being an alternate management approach to the preferred approach. But the disparity persisted, Dr. Black said. By 2007, the biopsy rate was 70% among black women and 83% among white (P less than .001).

The difference in SLND was also associated with a significantly increased rate of lymphedema. By 5 years after surgery, lymphedema had developed in 18% of black women who had an axillary node biopsy compared with 7% of white women who had a sentinel node biopsy. But when black women had a sentinel node biopsy, their 5-year rate of lymphedema was similar to the rate among white women (9%; P less than .001).

"This shows that if black women had gotten the appropriate surgery, they were not at any increased risk for lymphedema," Dr. Black said.

She intends to reanalyze the groups when the 2010 SEER data is released next spring. "We hope to see the disparity reduced in that analysis, although it may not be," she said in an interview. "If it’s not, we really need to figure out how we can work with national programs to disseminate guidelines and provide reminders to surgeons and multispecialist breast cancer teams – as well as to patients, so they can advocate for themselves. But it’s not only the patient’s responsibility. It’s a two-way street. We need to take some responsibility for this problem."

Dr. Black has no relevant financial relationships to disclose.

SAN ANTONIO – Black women are significantly less likely to receive a sentinel lymph node biopsy than are white women – and significantly more likely to develop lymphedema, a large database study has determined.

Among more than 31,000 women with invasive breast cancer diagnosed from 2002-2007, 62% of black women underwent the procedure, compared with 74% of white women – a significant difference (P less than .001).

That disparity led to a doubling in the risk of lymphedema in black women, compared with white women, Dr. Dalliah Black said at the San Antonio Breast Cancer Symposium. Axillary sentinel lymph node biopsy (SLNB) is a less-invasive alternative to axillary lymph node dissection (ALND) for breast cancer staging.

The disparity appears to be regional, said Dr. Black of the University of Texas M.D. Anderson Cancer Center in Houston. A preliminary subanalysis of 12 regions in the database found that Louisiana had the lowest rate of sentinel node biopsy among blacks (58%), while Seattle had the highest (89%). Regional differences were related not only to the patient’s socioeconomic status but to the numbers of surgeons available in the region.

Dr. Black used data extracted from the U.S. national Surveillance, Epidemiology, and End Results (SEER) database. The patient group consisted of 31,274 women diagnosed between 2002 and 2007. All patients had invasive breast cancer with no evidence of distant metastasis and underwent a documented axillary surgical procedure. All of the patients had fee-for-service coverage.

Black women composed 6% of the group (1,767). The median age was 74 years; 75% of the patients had a tumor size of 2 cm or smaller. Most (62%) had undergone a lumpectomy, and 73%, a sentinel lymph node biopsy.

The median number of sentinel nodes removed was two, and the median number of axillary nodes, 11.

The rate of sentinel node biopsy increased in both groups over the study period, as the surgery moved from being an alternate management approach to the preferred approach. But the disparity persisted, Dr. Black said. By 2007, the biopsy rate was 70% among black women and 83% among white (P less than .001).

The difference in SLND was also associated with a significantly increased rate of lymphedema. By 5 years after surgery, lymphedema had developed in 18% of black women who had an axillary node biopsy compared with 7% of white women who had a sentinel node biopsy. But when black women had a sentinel node biopsy, their 5-year rate of lymphedema was similar to the rate among white women (9%; P less than .001).

"This shows that if black women had gotten the appropriate surgery, they were not at any increased risk for lymphedema," Dr. Black said.

She intends to reanalyze the groups when the 2010 SEER data is released next spring. "We hope to see the disparity reduced in that analysis, although it may not be," she said in an interview. "If it’s not, we really need to figure out how we can work with national programs to disseminate guidelines and provide reminders to surgeons and multispecialist breast cancer teams – as well as to patients, so they can advocate for themselves. But it’s not only the patient’s responsibility. It’s a two-way street. We need to take some responsibility for this problem."

Dr. Black has no relevant financial relationships to disclose.

SAN DIEGO – A Rapid Quality Reporting System significantly improved oncologists’ adherence to five measures of quality treatment for patients with breast and colon cancer during beta testing involving 64,129 patients at 64 cancer centers.

The system, developed by the American College of Surgeons’ Commission on Cancer, provides next-business-day feedback when centers submit data. Compliance rates climbed as high as 90% by the end of a 5-year period, according to researchers.

Erica J. McNamara and her associates reported the following gains at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO):

• The proportion of patients receiving hormone therapy for hormone receptor–positive breast cancer increased from 47% in 2006 to 85% in 2011.

• Treatment with radiation following breast conserving surgery increased from 69% of patients to 90%.

• Use of multi-adjuvant chemotherapy for hormone receptor–negative breast cancer increased from 72% of patients to 90%,

• Treatment with adjuvant chemotherapy for lymph node–positive colon cancer increased from 68% to 86%.

• The proportion of patients with resected colon cancer who had at least 12 regional lymph nodes removed for pathological examination improved from 70% to 90%,

The study gathered data from the National Cancer Database in 2006-2007 for 18,151 patients with breast cancer and 6,369 patients with colon cancer and compared it with data reported to the Rapid Quality Reporting System (RQRS) in 2008-2011 for 31,590 patients with breast cancer and 11,338 patients with colon cancer.

The system monitors the five quality measures using reporting procedures similar to those that hospitals already use to submit patient data to cancer registries. Traditional registries generally report a hospital’s rate of performing quality measures 2 years after data submission, however, while the RQRS allows cancer programs to submit data whenever they want and sends feedback by the next business day, said Ms. McNamara, a quality improvement information analyst for the American College of Surgeons, Chicago.

With as little as a surgical or pathological report, cancer programs can submit a case to the RQRS to get alerts when quality care is not being provided. "What this does is it changes it from looking at retrospective cases to cases that are currently within their first course of therapy," she said in a press conference before the meeting.

Programs participating in the beta-test generally submitted data monthly, and new participants in the RQRS are required to submit data at least quarterly. The RQRS analyzes the data and returns a report in a variety of image formats, such as a year-to-date "dashboard" showing the program’s compliance rates for individual quality measures, and a list of every case submitted and whether the quality measures were applicable to the case or not, or if more information is needed.

The report also includes color-coded "case alerts" with the colors changing to orange and then red as a patient gets closer to the end of the first course of therapy with either no documentation of adjuvant therapy or no documentation that treatment decision has been made to not provide adjuvant therapy. Participants must log in to a password-protected site to view details of the case.

"For each of the adjuvant therapy measures, there’s a specific amount of time that each patient has to receive their adjuvant therapy," Ms. McNamara said. "We find that after about 6-9 months of using RQRS, about a third of programs tell us that they have seen RQRS prevent patients from slipping through the cracks or not receiving timely adjuvant care."

Breakdowns of the data by race, age, and type of insurance showed that quality care significantly improved in all subgroups. Disparities in quality adherence rates between patients of different races, ages, or insurance status were minimized or eliminated with use of the RQRS.

Two factors appeared to produce these improvements. Use of the RQRS improved the coordination of care and led to more complete reporting of adjuvant therapy data, she said.

More than 400 cancer programs now voluntarily use the RQRS. The American College of Surgeons is working on expanding the RQRS to include other measures of quality care for breast cancer and for lung, stomach, and esophageal cancers.

Ms. McNamara reported having no financial disclosures.

SAN DIEGO – A Rapid Quality Reporting System significantly improved oncologists’ adherence to five measures of quality treatment for patients with breast and colon cancer during beta testing involving 64,129 patients at 64 cancer centers.

The system, developed by the American College of Surgeons’ Commission on Cancer, provides next-business-day feedback when centers submit data. Compliance rates climbed as high as 90% by the end of a 5-year period, according to researchers.

Erica J. McNamara and her associates reported the following gains at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO):

• The proportion of patients receiving hormone therapy for hormone receptor–positive breast cancer increased from 47% in 2006 to 85% in 2011.

• Treatment with radiation following breast conserving surgery increased from 69% of patients to 90%.

• Use of multi-adjuvant chemotherapy for hormone receptor–negative breast cancer increased from 72% of patients to 90%,

• Treatment with adjuvant chemotherapy for lymph node–positive colon cancer increased from 68% to 86%.

• The proportion of patients with resected colon cancer who had at least 12 regional lymph nodes removed for pathological examination improved from 70% to 90%,

The study gathered data from the National Cancer Database in 2006-2007 for 18,151 patients with breast cancer and 6,369 patients with colon cancer and compared it with data reported to the Rapid Quality Reporting System (RQRS) in 2008-2011 for 31,590 patients with breast cancer and 11,338 patients with colon cancer.

The system monitors the five quality measures using reporting procedures similar to those that hospitals already use to submit patient data to cancer registries. Traditional registries generally report a hospital’s rate of performing quality measures 2 years after data submission, however, while the RQRS allows cancer programs to submit data whenever they want and sends feedback by the next business day, said Ms. McNamara, a quality improvement information analyst for the American College of Surgeons, Chicago.

With as little as a surgical or pathological report, cancer programs can submit a case to the RQRS to get alerts when quality care is not being provided. "What this does is it changes it from looking at retrospective cases to cases that are currently within their first course of therapy," she said in a press conference before the meeting.

Programs participating in the beta-test generally submitted data monthly, and new participants in the RQRS are required to submit data at least quarterly. The RQRS analyzes the data and returns a report in a variety of image formats, such as a year-to-date "dashboard" showing the program’s compliance rates for individual quality measures, and a list of every case submitted and whether the quality measures were applicable to the case or not, or if more information is needed.

The report also includes color-coded "case alerts" with the colors changing to orange and then red as a patient gets closer to the end of the first course of therapy with either no documentation of adjuvant therapy or no documentation that treatment decision has been made to not provide adjuvant therapy. Participants must log in to a password-protected site to view details of the case.

"For each of the adjuvant therapy measures, there’s a specific amount of time that each patient has to receive their adjuvant therapy," Ms. McNamara said. "We find that after about 6-9 months of using RQRS, about a third of programs tell us that they have seen RQRS prevent patients from slipping through the cracks or not receiving timely adjuvant care."

Breakdowns of the data by race, age, and type of insurance showed that quality care significantly improved in all subgroups. Disparities in quality adherence rates between patients of different races, ages, or insurance status were minimized or eliminated with use of the RQRS.

Two factors appeared to produce these improvements. Use of the RQRS improved the coordination of care and led to more complete reporting of adjuvant therapy data, she said.

More than 400 cancer programs now voluntarily use the RQRS. The American College of Surgeons is working on expanding the RQRS to include other measures of quality care for breast cancer and for lung, stomach, and esophageal cancers.

Ms. McNamara reported having no financial disclosures.

SAN DIEGO – A Rapid Quality Reporting System significantly improved oncologists’ adherence to five measures of quality treatment for patients with breast and colon cancer during beta testing involving 64,129 patients at 64 cancer centers.

The system, developed by the American College of Surgeons’ Commission on Cancer, provides next-business-day feedback when centers submit data. Compliance rates climbed as high as 90% by the end of a 5-year period, according to researchers.

Erica J. McNamara and her associates reported the following gains at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO):

• The proportion of patients receiving hormone therapy for hormone receptor–positive breast cancer increased from 47% in 2006 to 85% in 2011.

• Treatment with radiation following breast conserving surgery increased from 69% of patients to 90%.

• Use of multi-adjuvant chemotherapy for hormone receptor–negative breast cancer increased from 72% of patients to 90%,

• Treatment with adjuvant chemotherapy for lymph node–positive colon cancer increased from 68% to 86%.

• The proportion of patients with resected colon cancer who had at least 12 regional lymph nodes removed for pathological examination improved from 70% to 90%,

The study gathered data from the National Cancer Database in 2006-2007 for 18,151 patients with breast cancer and 6,369 patients with colon cancer and compared it with data reported to the Rapid Quality Reporting System (RQRS) in 2008-2011 for 31,590 patients with breast cancer and 11,338 patients with colon cancer.

The system monitors the five quality measures using reporting procedures similar to those that hospitals already use to submit patient data to cancer registries. Traditional registries generally report a hospital’s rate of performing quality measures 2 years after data submission, however, while the RQRS allows cancer programs to submit data whenever they want and sends feedback by the next business day, said Ms. McNamara, a quality improvement information analyst for the American College of Surgeons, Chicago.

With as little as a surgical or pathological report, cancer programs can submit a case to the RQRS to get alerts when quality care is not being provided. "What this does is it changes it from looking at retrospective cases to cases that are currently within their first course of therapy," she said in a press conference before the meeting.

Programs participating in the beta-test generally submitted data monthly, and new participants in the RQRS are required to submit data at least quarterly. The RQRS analyzes the data and returns a report in a variety of image formats, such as a year-to-date "dashboard" showing the program’s compliance rates for individual quality measures, and a list of every case submitted and whether the quality measures were applicable to the case or not, or if more information is needed.

The report also includes color-coded "case alerts" with the colors changing to orange and then red as a patient gets closer to the end of the first course of therapy with either no documentation of adjuvant therapy or no documentation that treatment decision has been made to not provide adjuvant therapy. Participants must log in to a password-protected site to view details of the case.

"For each of the adjuvant therapy measures, there’s a specific amount of time that each patient has to receive their adjuvant therapy," Ms. McNamara said. "We find that after about 6-9 months of using RQRS, about a third of programs tell us that they have seen RQRS prevent patients from slipping through the cracks or not receiving timely adjuvant care."

Breakdowns of the data by race, age, and type of insurance showed that quality care significantly improved in all subgroups. Disparities in quality adherence rates between patients of different races, ages, or insurance status were minimized or eliminated with use of the RQRS.

Two factors appeared to produce these improvements. Use of the RQRS improved the coordination of care and led to more complete reporting of adjuvant therapy data, she said.

More than 400 cancer programs now voluntarily use the RQRS. The American College of Surgeons is working on expanding the RQRS to include other measures of quality care for breast cancer and for lung, stomach, and esophageal cancers.

Ms. McNamara reported having no financial disclosures.

Among breast cancer patients, women who worry the most that localized cancer in one breast will spread to the other breast are twice as likely to choose a prophylactic double mastectomy – even though most of them have no clinical indication for the procedure, a study of 1,446 patients showed.

Approximately 80% of the 107 women in the study who chose prophylactic double mastectomy had a very low risk for contralateral disease, Sarah T. Hawley, Ph.D., said in a press conference sponsored by the American Society of Clinical Oncology (ASCO).

She is slated to present the results at a symposium on quality care sponsored by the American Society of Clinical Oncology, taking place Nov. 30 to Dec. 1 in San Diego.

Many women undergo unnecessary surgery out of ungrounded fear that cancer in one breast will lead to cancer in the other, said Dr. Hawley of the division of general medicine at the University of Michigan, Ann Arbor.

Women’s worry about cancer spreading from one breast to the other "really shouldn’t be a reason to get that procedure," she said.

Contralateral prophylactic mastectomy can be considered if a patient is positive for BRCA1 or BRCA2 mutations or has a family history of breast or ovarian cancer in two or more first-degree relatives, according to Society of Surgical Oncology guidelines.

"Despite the small number of women who meet these criteria, rates of contralateral prophylactic mastectomy have been increasing in recent years," Dr. Hawley noted.

Those traditional indications still were powerful drivers in the study – a positive genetic test increased the odds of contralateral prophylactic mastectomy 10-fold, and a family history increased the odds 5-fold.

The doubling in odds of contralateral prophylactic mastectomy in women with a high level of worry (compared with low worry level) is notable because the prophylactic surgery has not been known to reduce the risk of recurrence when those indications are not present, as was the case with the majority of women who chose the procedure in the study.

Among women who chose contralateral prophylactic mastectomy, 90% reported high levels of worry, compared with 80% of the 564 women who underwent single-breast mastectomy, a statistically significant difference, Dr. Hawley reported.

She and her associates studied 1,446 newly diagnosed breast cancer patients who completed two surveys 4 years apart, had not had a recurrence during that time, and had complete data on genetic testing and family history. Contralateral prophylactic mastectomy was considered by 35% of the whole cohort and chosen by 7%. Among women who underwent mastectomy of the cancerous breast, 53% considered contralateral prophylactic mastectomy and 19% underwent the procedure.

When women were considering any mastectomy vs. breast conservation surgery, family history and genetic test results did not significantly affect the odds that they would choose any mastectomy, but their level of worry did. High levels of worry significantly increased the odds of mastectomy by 69% in a subanalysis that controlled for the effects of age, race or ethnicity, education, and cancer stage.

A separate subanalysis found that both clinical indications and worry affected the likelihood of contralateral prophylactic mastectomy compared with unilateral mastectomy. The odds of having the prophylactic surgery increased more than 4-fold with a family history of at least two primary relatives with breast cancer, more than 10-fold with a positive genetic test, and more than 2-fold with a high degree of worry in the multivariate analysis, Dr. Hawley said.

Compared with previous studies on why women are getting contralateral prophylactic mastectomy, the current study is larger; is population-based; contains racial and ethnic samples; and includes data on patient attitudes, genetic testing, and type of family history (not just any family history), she said.

Dr. Jyoti D. Patel, moderator of the press conference, said the findings suggest that "we, as physicians, may not be adequately educating our patients about the risk for recurrent disease."

In general, women with localized breast cancer in one breast have less than a 1% chance of developing a new cancer in the unaffected breast and an 8% chance of recurrence in the affected breast or a nearby lymph node. The risk for developing a new cancer in the contralateral breast rises to approximately 10%-15% if the patient has a history of breast or ovarian cancer in two or more primary relatives, with a similar or slightly greater increased risk from a positive genetic mutation, Dr. Patel estimated. Having both clinical risk factors confers a 10- to 20-fold increase in risk.

Unfortunately, many women overestimate their risk of developing breast cancer in the contralateral breast and undergo unnecessary surgery, she commented. This study suggests that physicians re-examine how they communicate with their patients regarding the decision to undergo prophylactic mastectomy.

"Many women fear recurrence, and they also fear surveillance. They worry about, if they’re 35 years old, what a lifetime of screening for the contralateral breast might look like if they end up getting multiple biopsies. So how we put that in perspective for our young population will become vitally important," said Dr. Patell, a thoracic oncologist at Northwestern University in Chicago and a member of ASCO’s Cancer Communications Committee.

Dr. Hawley reported having no financial disclosures.

Among breast cancer patients, women who worry the most that localized cancer in one breast will spread to the other breast are twice as likely to choose a prophylactic double mastectomy – even though most of them have no clinical indication for the procedure, a study of 1,446 patients showed.

Approximately 80% of the 107 women in the study who chose prophylactic double mastectomy had a very low risk for contralateral disease, Sarah T. Hawley, Ph.D., said in a press conference sponsored by the American Society of Clinical Oncology (ASCO).

She is slated to present the results at a symposium on quality care sponsored by the American Society of Clinical Oncology, taking place Nov. 30 to Dec. 1 in San Diego.

Many women undergo unnecessary surgery out of ungrounded fear that cancer in one breast will lead to cancer in the other, said Dr. Hawley of the division of general medicine at the University of Michigan, Ann Arbor.

Women’s worry about cancer spreading from one breast to the other "really shouldn’t be a reason to get that procedure," she said.

Contralateral prophylactic mastectomy can be considered if a patient is positive for BRCA1 or BRCA2 mutations or has a family history of breast or ovarian cancer in two or more first-degree relatives, according to Society of Surgical Oncology guidelines.

"Despite the small number of women who meet these criteria, rates of contralateral prophylactic mastectomy have been increasing in recent years," Dr. Hawley noted.

Those traditional indications still were powerful drivers in the study – a positive genetic test increased the odds of contralateral prophylactic mastectomy 10-fold, and a family history increased the odds 5-fold.

The doubling in odds of contralateral prophylactic mastectomy in women with a high level of worry (compared with low worry level) is notable because the prophylactic surgery has not been known to reduce the risk of recurrence when those indications are not present, as was the case with the majority of women who chose the procedure in the study.

Among women who chose contralateral prophylactic mastectomy, 90% reported high levels of worry, compared with 80% of the 564 women who underwent single-breast mastectomy, a statistically significant difference, Dr. Hawley reported.

She and her associates studied 1,446 newly diagnosed breast cancer patients who completed two surveys 4 years apart, had not had a recurrence during that time, and had complete data on genetic testing and family history. Contralateral prophylactic mastectomy was considered by 35% of the whole cohort and chosen by 7%. Among women who underwent mastectomy of the cancerous breast, 53% considered contralateral prophylactic mastectomy and 19% underwent the procedure.

When women were considering any mastectomy vs. breast conservation surgery, family history and genetic test results did not significantly affect the odds that they would choose any mastectomy, but their level of worry did. High levels of worry significantly increased the odds of mastectomy by 69% in a subanalysis that controlled for the effects of age, race or ethnicity, education, and cancer stage.

A separate subanalysis found that both clinical indications and worry affected the likelihood of contralateral prophylactic mastectomy compared with unilateral mastectomy. The odds of having the prophylactic surgery increased more than 4-fold with a family history of at least two primary relatives with breast cancer, more than 10-fold with a positive genetic test, and more than 2-fold with a high degree of worry in the multivariate analysis, Dr. Hawley said.

Compared with previous studies on why women are getting contralateral prophylactic mastectomy, the current study is larger; is population-based; contains racial and ethnic samples; and includes data on patient attitudes, genetic testing, and type of family history (not just any family history), she said.

Dr. Jyoti D. Patel, moderator of the press conference, said the findings suggest that "we, as physicians, may not be adequately educating our patients about the risk for recurrent disease."

In general, women with localized breast cancer in one breast have less than a 1% chance of developing a new cancer in the unaffected breast and an 8% chance of recurrence in the affected breast or a nearby lymph node. The risk for developing a new cancer in the contralateral breast rises to approximately 10%-15% if the patient has a history of breast or ovarian cancer in two or more primary relatives, with a similar or slightly greater increased risk from a positive genetic mutation, Dr. Patel estimated. Having both clinical risk factors confers a 10- to 20-fold increase in risk.

Unfortunately, many women overestimate their risk of developing breast cancer in the contralateral breast and undergo unnecessary surgery, she commented. This study suggests that physicians re-examine how they communicate with their patients regarding the decision to undergo prophylactic mastectomy.

"Many women fear recurrence, and they also fear surveillance. They worry about, if they’re 35 years old, what a lifetime of screening for the contralateral breast might look like if they end up getting multiple biopsies. So how we put that in perspective for our young population will become vitally important," said Dr. Patell, a thoracic oncologist at Northwestern University in Chicago and a member of ASCO’s Cancer Communications Committee.

Dr. Hawley reported having no financial disclosures.

Among breast cancer patients, women who worry the most that localized cancer in one breast will spread to the other breast are twice as likely to choose a prophylactic double mastectomy – even though most of them have no clinical indication for the procedure, a study of 1,446 patients showed.

Approximately 80% of the 107 women in the study who chose prophylactic double mastectomy had a very low risk for contralateral disease, Sarah T. Hawley, Ph.D., said in a press conference sponsored by the American Society of Clinical Oncology (ASCO).

She is slated to present the results at a symposium on quality care sponsored by the American Society of Clinical Oncology, taking place Nov. 30 to Dec. 1 in San Diego.

Many women undergo unnecessary surgery out of ungrounded fear that cancer in one breast will lead to cancer in the other, said Dr. Hawley of the division of general medicine at the University of Michigan, Ann Arbor.

Women’s worry about cancer spreading from one breast to the other "really shouldn’t be a reason to get that procedure," she said.

Contralateral prophylactic mastectomy can be considered if a patient is positive for BRCA1 or BRCA2 mutations or has a family history of breast or ovarian cancer in two or more first-degree relatives, according to Society of Surgical Oncology guidelines.

"Despite the small number of women who meet these criteria, rates of contralateral prophylactic mastectomy have been increasing in recent years," Dr. Hawley noted.

Those traditional indications still were powerful drivers in the study – a positive genetic test increased the odds of contralateral prophylactic mastectomy 10-fold, and a family history increased the odds 5-fold.

The doubling in odds of contralateral prophylactic mastectomy in women with a high level of worry (compared with low worry level) is notable because the prophylactic surgery has not been known to reduce the risk of recurrence when those indications are not present, as was the case with the majority of women who chose the procedure in the study.

Among women who chose contralateral prophylactic mastectomy, 90% reported high levels of worry, compared with 80% of the 564 women who underwent single-breast mastectomy, a statistically significant difference, Dr. Hawley reported.

She and her associates studied 1,446 newly diagnosed breast cancer patients who completed two surveys 4 years apart, had not had a recurrence during that time, and had complete data on genetic testing and family history. Contralateral prophylactic mastectomy was considered by 35% of the whole cohort and chosen by 7%. Among women who underwent mastectomy of the cancerous breast, 53% considered contralateral prophylactic mastectomy and 19% underwent the procedure.

When women were considering any mastectomy vs. breast conservation surgery, family history and genetic test results did not significantly affect the odds that they would choose any mastectomy, but their level of worry did. High levels of worry significantly increased the odds of mastectomy by 69% in a subanalysis that controlled for the effects of age, race or ethnicity, education, and cancer stage.

A separate subanalysis found that both clinical indications and worry affected the likelihood of contralateral prophylactic mastectomy compared with unilateral mastectomy. The odds of having the prophylactic surgery increased more than 4-fold with a family history of at least two primary relatives with breast cancer, more than 10-fold with a positive genetic test, and more than 2-fold with a high degree of worry in the multivariate analysis, Dr. Hawley said.

Compared with previous studies on why women are getting contralateral prophylactic mastectomy, the current study is larger; is population-based; contains racial and ethnic samples; and includes data on patient attitudes, genetic testing, and type of family history (not just any family history), she said.

Dr. Jyoti D. Patel, moderator of the press conference, said the findings suggest that "we, as physicians, may not be adequately educating our patients about the risk for recurrent disease."

In general, women with localized breast cancer in one breast have less than a 1% chance of developing a new cancer in the unaffected breast and an 8% chance of recurrence in the affected breast or a nearby lymph node. The risk for developing a new cancer in the contralateral breast rises to approximately 10%-15% if the patient has a history of breast or ovarian cancer in two or more primary relatives, with a similar or slightly greater increased risk from a positive genetic mutation, Dr. Patel estimated. Having both clinical risk factors confers a 10- to 20-fold increase in risk.

Unfortunately, many women overestimate their risk of developing breast cancer in the contralateral breast and undergo unnecessary surgery, she commented. This study suggests that physicians re-examine how they communicate with their patients regarding the decision to undergo prophylactic mastectomy.

"Many women fear recurrence, and they also fear surveillance. They worry about, if they’re 35 years old, what a lifetime of screening for the contralateral breast might look like if they end up getting multiple biopsies. So how we put that in perspective for our young population will become vitally important," said Dr. Patell, a thoracic oncologist at Northwestern University in Chicago and a member of ASCO’s Cancer Communications Committee.

Dr. Hawley reported having no financial disclosures.